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Completed

NCT Number: NCT05814107

Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd., Melbourne, Australia

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About this study

This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants 18-65 years old, inclusive
  • BMI of 25 - 40, inclusive
  • Stable body weight for two months

Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:

  • Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%

Exclusion criteria

  • History of significant medical conditions and malignancy
  • Uncontrollable hypertension
  • History of alcoholism or drug addiction within 1 year prior to Screening
  • Current or recent participation in an investigational clinical trial

Treatment and study plan

CT-996

Drug

Capsule of CT-996

Other names: RO7795081, RG6652

Placebo

Drug

Capsule of placebo matching CT-996.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  2. Time to Maximum Observed Plasma Concentration (Tmax) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  3. Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  4. AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  5. Apparent Terminal Elimination Half-Life (t1/2) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  6. Part 1 Cohorts: Clearance (CL) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5

  7. Part 1 Cohorts: Volume of Distribution (V) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 5

  8. Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 33

  9. Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 33

  10. Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996

    Time frame: At prespecified timepoints from Day 1 to Day 33

  11. Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996

    Time frame: At prespecified timepoints for up to 14 days

    Determine the effect of a high-fat meal on the PK of CT-996 following a single dose

  12. Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996

    Time frame: At prespecified timepoints for up to 14 days

    Determine the effect of a high-fat meal on the PK of CT-996 following a single dose

Sponsors and collaborators

Lead sponsor

Carmot Australia First Pty Ltd

Industry

Collaborators

  • Carmot Therapeutics, Inc.
  • Hoffmann-La Roche

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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